Type B Aortic DissectionNCT07779291
Research on Predicting Aortic Remodeling Following TEVAR for Type B Aortic Dissection Based on VDM and CFD
An observational study of Type B Aortic Dissection and Tevar, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites in China.
Trial summary
This study proposes a retrospective analysis that systematically integrates multidimensional biomechanical and anatomical data to construct an early and accurate predictive model for adverse aortic remodeling following thoracic endovascular aortic repair (TEVAR) in patients with Type B aortic dissection (TBAD). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Type B Aortic Dissection, Tevar, CFD
- What is being tested?
- Thoracic Endovascular Aortic Repair
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 3 sitesChina
- Study dates
- 1 Jan 2020to 1 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study population comprises patients diagnosed with acute uncomplicated Type B aortic dissection who underwent thoracic endovascular aortic repair (TEVAR) at a single center. Eligible patients were aged 18 to 85 years, male or non-pregnant female, and had at least one preoperative and three postoperative CTA examinations with adequate imaging coverage from the brachiocephalic trunk to the iliac arteries. Patients with traumatic or iatrogenic dissection, chronic or complicated dissection, penetrating aortic ulcer (PAU), intramural hematoma (IMH), localized dissection, connective tissue disorders (e.g., Marfan syndrome), prior cardiac or aortic surgery, insufficient imaging quality, or failed image registration for VDM analysis were excluded. A total of 1000 patients were enrolled and followed for up to 5 years post-TEVAR to assess adverse aortic remodeling outcomes.
Who may be able to join
- Age between 18 and 85 years, male or non-pregnant female. (2) CTA-confirmed diagnosis of Type B aortic dissection, classified as acute uncomplicated dissection. (3) Underwent TEVAR (thoracic endovascular aortic repair) procedure. (4) At least one preoperative and three postoperative CTA examinations available, with imaging coverage extending cranially to include the brachiocephalic trunk, left common carotid artery, and the origin of the left subclavian artery, and caudally to cover the origins of the internal and external iliac arteries.
Who cannot join
- Age <18 or >85 years. (2) Traumatic or iatrogenic dissection, or isolated aortic aneurysm. (3) Chronic or complicated dissection. (4) Penetrating aortic ulcer (PAU) or intramural hematoma (IMH), as well as localized dissection. (5) Connective tissue disorders, such as Marfan syndrome. (6) Prior history of cardiac or aortic surgery. (7) Absence of signed surgical informed consent. (8) Insufficient CTA examinations or inadequate imaging coverage/quality. (9) Failure of image registration precluding completion of the VDM analysis workflow.
Trial locations and contacts
3 sites in 1 country.
China3 sites
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
About this study
This study proposes a retrospective analysis that systematically integrates multidimensional biomechanical and anatomical data to construct an early and accurate predictive model for adverse aortic remodeling following thoracic endovascular aortic repair (TEVAR) in patients with Type B aortic dissection (TBAD). Postoperative follow-up CTA images will be analyzed using vascular deformation mapping (VDM) technology, which enables quantitative assessment of regional aortic deformation and strain evolution through high-precision three-dimensional registration, thereby overcoming the limitations of conventional diameter-based measurements. Concurrently, patient-specific computational fluid dynamics (CFD) models will be reconstructed from preoperative CTA data to simulate the hemodynamic environment within the dissected aorta, extracting key parameters including wall shear stress, flow velocity, and pressure distribution to quantify the mechanical forces driving vascular remodeling. Furthermore, the anatomical characteristics of entry tears-including their number, spatial distribution, and size-will be systematically characterized. By integrating these three dimensions of indicators and employing multivariable regression and machine learning algorithms, independent risk factors significantly associated with adverse events such as false lumen aneurysmal expansion, aortic rupture, and recurrent dissection will be identified, ultimately establishing a comprehensive predictive model that combines sensitivity, objectivity, and clinical feasibility. The development of this model is expected to provide clinicians with quantitative decision support for early identification of high-risk patients, formulation of individualized surveillance strategies, and implementation of timely interventions, thereby substantially improving the long-term prognosis and quality of life for TBAD patients following TEVAR.
Read the detailed description
Inclusion Criteria: (1) Age between 18 and 85 years, male or non-pregnant female. (2) CTA-confirmed diagnosis of Type B aortic dissection, classified as acute uncomplicated dissection. (3) Underwent TEVAR (thoracic endovascular aortic repair) procedure. (4) At least one preoperative and three postoperative CTA examinations available, with imaging coverage extending cranially to include the brachiocephalic trunk, left common carotid artery, and the origin of the left subclavian artery, and caudally to cover the origins of the internal and external iliac arteries.
Exclusion Criteria: (1) Age <18 or >85 years. (2) Traumatic or iatrogenic dissection, or isolated aortic aneurysm. (3) Chronic or complicated dissection. (4) Penetrating aortic ulcer (PAU) or intramural hematoma (IMH), as well as localized dissection. (5) Connective tissue disorders, such as Marfan syndrome. (6) Prior history of cardiac or aortic surgery. (7) Absence of signed surgical informed consent. (8) Insufficient CTA examinations or inadequate imaging coverage/quality. (9) Failure of image registration precluding completion of the VDM analysis workflow.
- Conditions
- Type B Aortic Dissection, Tevar, CFD
- Being tested
- Thoracic Endovascular Aortic Repair
- Keywords
- Type B aortic dissection, TEVAR, adverse aortic remodeling, vascular deformation mapping, computational fluid dynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Endovascular Aortic RepairProcedure or surgery
Thoracic endovascular aortic repair (TEVAR) with commercially available stent-graft devices, implanted via femoral arterial access under fluoroscopic guidance. The intervention involves covering the primary entry tear with a stent-graft to redirect blood flow into the true lumen.
| Study group | Role | What they receive |
|---|---|---|
| TEVAR-TBAD Cohort | TEVAR using commercially available stent-grafts via femoral access, covering the primary entry tear to promote false lumen thrombosis and aortic remodeling. This single-arm cohort includes acute uncomplicated TBAD patients treated with TEVAR, with adequate pre- and post-operative CTA imaging. Exclusions include connective tissue disorders, traumatic/iatrogenic dissection, PAU/IMH, prior aortic surgery, and insufficient imaging quality. The cohort is analyzed retrospectively using VDM, CFD, and tear morphology to predict adverse remodeling outcomes Receives: Procedure: Thoracic Endovascular Aortic Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of Adverse Aortic Remodeling
A composite endpoint defined as the occurrence of any of the following events during follow-up: (1) aneurysmal dilation of the stented or distal aorta to ≥5.0 cm; (2) aneurysmal dilation rate ≥0.5 cm/year; (3) rupture or signs of imminent rupture; (4) visceral and/or lower limb malperfusion; (5) distal stent-induced new entry (d-SINE); (6) Type I, II, III, or R endoleak.
Measured: Up to 5 years post-procedure
Secondary outcomes (6)
All-Cause Mortality
Death from any cause during follow-up.
Measured: Up to 5 years post-procedure
Aortic-Related Mortality
Death related to progression of aortic dissection or complications following TEVAR during follow-up.
Measured: Up to 5 years post-procedure
Aortic-Related Secondary Intervention Rate
Rate of secondary interventions related to progression of aortic dissection or complications from the initial TEVAR procedure. Indications for secondary intervention include: Type I/III endoleak, Type II endoleak with concomitant false lumen aneurysmal dilation, retrograde Type A dissection (RTAD), distal stent-induced new entry (d-SINE) causing pain or persistent false lumen perfusion, distal aneurysmal dilation, and left subclavian artery (LSA) steal syndrome due to LSA coverage during the initial intervention. Secondary intervention strategies include: endovascular approaches (repeat stent-graft implantation, branch artery stenting, chimney/periscope techniques, coil embolization) and open surgical approaches (artificial vascular graft replacement, supra-aortic or visceral branch artery bypass/transposition).
Measured: Up to 5 years post-procedure
Visceral Artery Branch Lumen Loss Rate
Rate of visceral artery branch lumen loss during follow-up, assessed by serial CTA imaging.
Measured: Up to 5 years post-procedure
False Lumen Thrombosis Status
Degree of false lumen thrombosis assessed by serial CTA imaging during follow-up. Thrombosis status is categorized based on the extent of thrombus formation within the false lumen.
Measured: Up to 5 years post-procedure
Aortic-Related Adverse Events (AAEs) Rate
Rate of aortic-related adverse events (AAEs) during follow-up. AAEs are defined as a composite of: aortic-related death, major adverse cardiovascular events, stroke, acute renal insufficiency, rupture, spinal cord ischemia, mesenteric ischemia, lower limb ischemia, retrograde Type A dissection (RTAD), distal stent-induced new entry (d-SINE), stent-graft migration, stent-graft infection, and access site complications.
Measured: Up to 5 years post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Jan 2020
- Primary completion31 Dec 2025
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type B Aortic DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Wenzhou Medical University, Fudan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779291
- Sponsor's protocol ID
- 2026-0777
- Status last verified
- Jul 2026
- First submitted
- 19 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Predicting Aortic Remodeling Following TEVAR for Type B Aortic Dissection Based on VDM and CFD
- ClinicalTrials.gov ID
- NCT07779291
- Acronym / sponsor ID
- 2026-0777
- Conditions
- Type B Aortic Dissection, Tevar, CFD
- Keywords
- Type B aortic dissection, TEVAR, adverse aortic remodeling, vascular deformation mapping, computational fluid dynamics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Wenzhou Medical University, Fudan University
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study proposes a retrospective analysis that systematically integrates multidimensional biomechanical and anatomical data to construct an early and accurate predictive model for adverse aortic remodeling following thoracic endovascular aortic repair (TEVAR) in patients with Type B aortic dissection (TBAD). Postoperative follow-up CTA images will be analyzed using vascular deformation mapping (VDM) technology, which enables quantitative assessment of regional aortic deformation and strain evolution through high-precision three-dimensional registration, thereby overcoming the limitations of conventional diameter-based measurements. Concurrently, patient-specific computational fluid dynamics (CFD) models will be reconstructed from preoperative CTA data to simulate the hemodynamic environment within the dissected aorta, extracting key parameters including wall shear stress, flow velocity, and pressure distribution to quantify the mechanical forces driving vascular remodeling. Furthermore, the anatomical characteristics of entry tears-including their number, spatial distribution, and size-will be systematically characterized. By integrating these three dimensions of indicators and employing multivariable regression and machine learning algorithms, independent risk factors significantly associated with adverse events such as false lumen aneurysmal expansion, aortic rupture, and recurrent dissection will be identified, ultimately establishing a comprehensive predictive model that combines sensitivity, objectivity, and clinical feasibility. The development of this model is expected to provide clinicians with quantitative decision support for early identification of high-risk patients, formulation of individualized surveillance strategies, and implementation of timely interventions, thereby substantially improving the long-term prognosis and quality of life for TBAD patients following TEVAR.
Detailed description
Inclusion Criteria: (1) Age between 18 and 85 years, male or non-pregnant female. (2) CTA-confirmed diagnosis of Type B aortic dissection, classified as acute uncomplicated dissection. (3) Underwent TEVAR (thoracic endovascular aortic repair) procedure. (4) At least one preoperative and three postoperative CTA examinations available, with imaging coverage extending cranially to include the brachiocephalic trunk, left common carotid artery, and the origin of the left subclavian artery, and caudally to cover the origins of the internal and external iliac arteries.
Exclusion Criteria: (1) Age <18 or >85 years. (2) Traumatic or iatrogenic dissection, or isolated aortic aneurysm. (3) Chronic or complicated dissection. (4) Penetrating aortic ulcer (PAU) or intramural hematoma (IMH), as well as localized dissection. (5) Connective tissue disorders, such as Marfan syndrome. (6) Prior history of cardiac or aortic surgery. (7) Absence of signed surgical informed consent. (8) Insufficient CTA examinations or inadequate imaging coverage/quality. (9) Failure of image registration precluding completion of the VDM analysis workflow.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEVAR-TBAD Cohort | – | Procedure: Thoracic Endovascular Aortic RepairTEVAR using commercially available stent-grafts via femoral access, covering the primary entry tear to promote false lumen thrombosis and aortic remodeling. This single-arm cohort includes acute uncomplicated TBAD patients treated with TEVAR, with adequate pre- and post-operative CTA imaging. Exclusions include connective tissue disorders, traumatic/iatrogenic dissection, PAU/IMH, prior aortic surgery, and insufficient imaging quality. The cohort is analyzed retrospectively using VDM, CFD, and tear morphology to predict adverse remodeling outcomes |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study population comprises patients diagnosed with acute uncomplicated Type B aortic dissection who underwent thoracic endovascular aortic repair (TEVAR) at a single center. Eligible patients were aged 18 to 85 years, male or non-pregnant female, and had at least one preoperative and three postoperative CTA examinations with adequate imaging coverage from the brachiocephalic trunk to the iliac arteries. Patients with traumatic or iatrogenic dissection, chronic or complicated dissection, penetrating aortic ulcer (PAU), intramural hematoma (IMH), localized dissection, connective tissue disorders (e.g., Marfan syndrome), prior cardiac or aortic surgery, insufficient imaging quality, or failed image registration for VDM analysis were excluded. A total of 1000 patients were enrolled and followed for up to 5 years post-TEVAR to assess adverse aortic remodeling outcomes.
Key inclusion criteria (1 listed)
- Age between 18 and 85 years, male or non-pregnant female. (2) CTA-confirmed diagnosis of Type B aortic dissection, classified as acute uncomplicated dissection. (3) Underwent TEVAR (thoracic endovascular aortic repair) procedure. (4) At least one preoperative and three postoperative CTA examinations available, with imaging coverage extending cranially to include the brachiocephalic trunk, left common carotid artery, and the origin of the left subclavian artery, and caudally to cover the origins of the internal and external iliac arteries.
Key exclusion criteria (1 listed)
- Age <18 or >85 years. (2) Traumatic or iatrogenic dissection, or isolated aortic aneurysm. (3) Chronic or complicated dissection. (4) Penetrating aortic ulcer (PAU) or intramural hematoma (IMH), as well as localized dissection. (5) Connective tissue disorders, such as Marfan syndrome. (6) Prior history of cardiac or aortic surgery. (7) Absence of signed surgical informed consent. (8) Insufficient CTA examinations or inadequate imaging coverage/quality. (9) Failure of image registration precluding completion of the VDM analysis workflow.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic Endovascular Aortic RepairThoracic endovascular aortic repair (TEVAR) with commercially available stent-graft devices, implanted via femoral arterial access under fluoroscopic guidance. The intervention involves covering the primary entry tear with a stent-graft to redirect blood flow into the true lumen. | Procedure or surgery | TEVAR-TBAD Cohort |
Primary outcome
Composite of Adverse Aortic Remodeling
Time frame: Up to 5 years post-procedure
A composite endpoint defined as the occurrence of any of the following events during follow-up: (1) aneurysmal dilation of the stented or distal aorta to ≥5.0 cm; (2) aneurysmal dilation rate ≥0.5 cm/year; (3) rupture or signs of imminent rupture; (4) visceral and/or lower limb malperfusion; (5) distal stent-induced new entry (d-SINE); (6) Type I, II, III, or R endoleak.
6 secondary outcomes
All-Cause Mortality
Time frame: Up to 5 years post-procedure
Aortic-Related Mortality
Time frame: Up to 5 years post-procedure
Aortic-Related Secondary Intervention Rate
Time frame: Up to 5 years post-procedure
Visceral Artery Branch Lumen Loss Rate
Time frame: Up to 5 years post-procedure
False Lumen Thrombosis Status
Time frame: Up to 5 years post-procedure
Aortic-Related Adverse Events (AAEs) Rate
Time frame: Up to 5 years post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type B Aortic Dissection and Tevar, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of Adverse Aortic Remodeling (time frame: Up to 5 years post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.